Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05198791

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

Led by NHS National Waiting Times Centre Board · Updated on 2026-03-16

400

Participants Needed

2

Research Sites

234 weeks

Total Duration

On this page

Sponsors

N

NHS National Waiting Times Centre Board

Lead Sponsor

B

British Heart Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Patients with heart attack or heart injury are tested (angiogram) for blockages in their arteries. Patients may develop heart problems caused by damage to small (microvascular) blood vessels. Eplerenone, a mineralocorticoid receptor-selective antagonist, reduces blood vessel injury and is used to treat high blood pressure and heart failure. Aim: to test the use of eplerenone in patients with heart attack/heart injury an no obstructive coronary arteries and small vessel problems (coronary microvascular dysfunction). Patients admitted to hospitals in the West of Scotland (2.5 million) and referred for invasive management to the Golden Jubilee and Hairmyres hospitals because of a suspected heart attack heart will be invited to participate into a registry-based clinical trial. Screening, enrolment and verbal, informed consent will be obtained during the angiogram then written consent on the ward. Small vessel disease will be assessed using a 'diagnostic' guidewire during the standard angiogram. People with small vessel problems will be invited to participate in a clinical trial of usual care or eplerenone. Coronary microvascular dysfunction is defined as an index of microvascular resistance ≥25. Coronary flow reserve (CFR abnormal \<2.0), microvascular resistance reserve ratio (MRR, abnormal \<2.5), and resistance reserve ratio (RRR abnormal \<2.0), measured simultaneously with IMR, are predefined parameters of interest. Patients will be allocated into one of the 3 groups: * Group 1: Patients without coronary microvascular dysfunction. No eplerenone * Group 2: Patient with coronary microvascular dysfunction. Usual care, no eplerenone. * Group 3: Small vessels abnormal. Eplerenone tablets. The primary outcome for the trial will be reduced heart injury (biomarkers) in patients with microvascular disease. We will also test heart function (MRI scan) at enrolment and at six months. All patients (Groups 1, 2 and 3) will have an angiogram. Standard blood tests will be collected during the hospital stay, and then again at 1 and 6 months. Other outcomes include questionnaires (health status). We will gather information on longer-term health outcomes (hospitalisation, death) using confidential electronic record linkage. We will ask for permission to store blood samples for future research. The research will improve scientific knowledge about eplerenone therapy in this patient group. The study will create a repository of clinical samples and images which will provide vital data for studies of endotypes of myocardial infarction or injury with no obstructive coronary arteries.

CONDITIONS

Official Title

Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Acute myocardial infarction or myocardial injury without obstructive coronary arteries
  • At least one cardiovascular risk factor: age over 70, atrial fibrillation, diabetes, current smoking, eGFR 30-60 mL/min/1.73 m2, prior myocardial infarction, treated hypertension, or confirmed/suspected COVID-19
  • Undergoing coronary angiography
Not Eligible

You will not qualify if you...

  • Obstructive coronary artery disease
  • Left ventricular ejection fraction 40% or less with heart failure after myocardial infarction
  • Estimated glomerular filtration rate less than 30 mL/min/1.73 m2
  • Severe liver impairment
  • Women who are pregnant, breastfeeding, or of child-bearing potential without negative pregnancy test and not using effective contraception
  • Current treatment with mineralocorticoid receptor antagonists
  • Use of antifungal drugs ketoconazole or itraconazole
  • Use of antiviral drugs nelfinavir or ritonavir
  • Use of antibiotics clarithromycin or telithromycin
  • Use of nefazodone for depression
  • Combined use of ACE inhibitors and angiotensin receptor blockers
  • Contraindications to cardiovascular MRI such as severe claustrophobia or metallic foreign body
  • Contraindications to intravenous adenosine such as severe asthma, long QT syndrome, advanced heart block, or sick sinus syndrome
  • Lack of informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

University Hospital Hairmyres

East Kilbride, Lanarkshire, United Kingdom, G75 8RG

Actively Recruiting

2

Golden Jubilee National Hospital

Glasgow, United Kingdom

Actively Recruiting

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Research Team

C

Colin Berry, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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